ALEXANDRIA, Va., Nov. 6 -- United States Patent no. 12,459,986, issued on Nov. 4, was assigned to Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.).
"System and method for characterizing drug product impurities" was invented by Shunhai Wang (Ossining, N.Y.).
According to the abstract* released by the U.S. Patent & Trademark Office: "Systems and methods for characterizing low molecular weight (LMW) protein drug product impurities are provided. One embodiment uses hydrophilic interaction chromatography (HILIC) coupled to mass spectrometry analysis. After removal of the N-linked glycans from the protein drug product, for example an antibody drug product, the elution of LMW impurities from the HILIC column was determined by the size of the mol...